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Catalog Number EMAX2PLUS |
Device Problems
Device Alarm System (1012); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the console of the motor device was displaying an e6 error code (overheat warning) and would not run.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi - (b)(4).
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Event Description
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It was reported from china that during service and evaluation, it was determined that the console of the motor device was displaying an e6 error code (overheat warning) and would not run.It was further determined that the device failed pretest for safety assessment, and rotational speed assessment.It was noted in the service order that the device did not function and stopped working after an unspecified surgical procedure.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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